Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

Mechanical Complication of Intrauterine Device Clinical Trial

Official title:

: Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404622
• Other study ID #: shom
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2018
• Last updated: January 25, 2018
• Start date: September 20, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of current study is to compare the rates of IUCD expulsion and complications in immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean delivery)

Description:

Intrauterine devices (IUDs) are among the most effective forms of contraception, offering greater than 99% efficacy per year of use and are completely reversible .

Post-placental intrauterine device (IUD) insertion is a safe, convenient, and effective option for postpartum contraception. "Post-placental" refers to insertion within 10-15 minutes of placental delivery, after vaginal or cesarean delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age: 18 -45

• Singleton pregnancy at =32 weeks gestation at time of enrollment

• Voluntarily requesting to IUD placement for postpartum contraception

• Able to give consent and agree to the terms of the study

Exclusion Criteria:

1. Uterine anomaly that preventing replacement of IUD.

2. Chorioamnionitis (such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C).

3. Puerperal sepsis and unresolved postpartum hemorrhage.

4. IUD allergy (copper).

5. Systemic lupus erythematosus with severe thrombocytopenia

Related Conditions & MeSH terms

• Mechanical Complication of Intrauterine Device

Intervention

Drug:
• IUCD
IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
ALshaimaa Aboalhassan Ali

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expulsion	The time until expulsion of the IUD will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the IUD is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial	3 months
Secondary	Displacement	The displacement is diagnosed by doing trans-vaginal ultrasound that showed IUCD that displaced up or down word	3 months
Secondary	Infection	The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study.	3 months
Secondary	Bleeding	Irregular bleeding (including spotting, light bleeding, heavy or longer menstrual period) are common in the first 3 months and may persist.	3 months
Secondary	Perforation	The diagnosis of a perforation may be made by a transvaginal sonogram that shows no IUD within the uterus and an abdominal radiograph that show IUD within the abdominal cavity.	3 months